The entire docket
is available at the regulations.gov site, and it contains some 445
public submissions (one withdrawn), a lot of which, of course, make no
mention of imaging. So, I downloaded them all, searched for mentioning
of imaging, which narrows the field somewhat, and here is what I found
(with hyperlinks directly to the comment page). I have omitted mention
of comments related to the measures since my primary focus is on the
technical requirements, and I apologize in advance if I have missed (or
misinterpreted) a relevant comment.

Here I have itemized
the comments, and refrained (mostly) from too much editorializing ... I
will make a separate post with my interpretation of all this.

These are the ONC document comments not the CMS comments ...

Eastern Maine Healthcare Systems
- Imaging - want images "and/or" results to be "or" only (guess what
they don't want to bother providing ?) - ask whether this is just
radiology, or also cardiology or pathology (very good question, they
want only radiology) - don't want single sign on requirement - estimate
cost to implement in PACS to be $1M - View, Download and Transmit to 3rd
Party - they want this removed for images entirely - they reference the
mention of the NIH RFP to develop technology for this and claim it is
unreasonable to require developmental technology (clearly it was a
tactical error for ONC to mention this NIH RFP, since this is
off-the-shelf technology that has been around for years and is available
from commercial providers; surprising EMHS doesn't recognize this) -
they make a good point about ther being no mention of "how long"
information has to be available after last contact

Aware and a second comment
- doesn't call out specific sections but comments on general on how
good DICOM and JPEG 2000 are, how bad CDs and proprietary viewers are,
how bulky images are to transmit especially via email, and how links to
sources of streamed images in a standard format are good - all true, but
unfortunately they also ignore the importation use case in promoting
streaming whilst deprecating bulk transfer of DICOM images; I quote, "without the necessity to download, store and upload the massive DICOM files themselves" (Aware is, of course, a company that sells streaming software solutions, I note, uncharitably).

RSNA
- Imaging - recommends a complete set of diagnostic quality images in
DICOM format, and the use of reference pointers using WADO - View,
Download and Transmit to 3rd Party - agree with the proposal of DICOM
and XDR and XDM, with comments about practicality of a PKI, and
suggestion to include XDS.b also (nothing surprising or offensive to me
here, since I helped edit this comment).

Ascension Health
- Imaging - recommend dropping single sign on (due to their negative
experience trying it) - also report difficulties with using links (URL
embedding) in some systems - warn about the diagnostic quality of
displays and the very poor viewing software tools that are state of the
art - mention that network image distribution (CD replacement) solutions
are geared to providers and not patient portals - View, Download and
Transmit to 3rd Party - want to remove the entire provision due to
issues with codes, DIRECT protocol, CDA, etc., but do not comment on
imaging at all

HIMSS EHR Association
- Imaging - support requirement but via link and without single sign on
- View, Download and Transmit to 3rd Party - recommend deferment to
Stage 3, but do offer constructive suggestions about combining View in
non-diagnostic format with option to Download DICOM images, and also
suggest that "the patient should be able to identify the location of a study to be referred to another provider"
(not entirely clear what this means) - specifically oppose the
inclusion of a requirement to Download DICOM images though,
distinguishing the EHR from the PACS, stating that DICOM viewers are not
available online (!) - recommend staying with CD or DVD or USB - and
get this, "electronic communication of DICOM images ... is still a new area and will require more discovery"
- and they object to having to import DICOM images and prefer a
"significant subset" of JPEG images instead (my overall assessment of
these comments is that they are a little schizophrenic and probably
compiled from several contributors with varying degrees of experience
with imaging)

HIMSS - Imaging - what about non-digital practices and in-office versus outsourced imaging - does immediately available mean when image is taken or after narrative is produced ? - View, Download and Transmit to 3rd Party - technically challenging - images in separate PACS -
DICOM is not the best "patient facing" standard - link to PACS from EHR
works for [physician] viewing but not for patient portal - DICOM images
need specialized viewing software and are too large (for viewing and for
DIRECT transport) - same "the patient should be able to identify the location of a study to be referred to another provider" as the EHR Association

Medical Information Technology
- Imaging - support a link without single sign-on - View, Download and
Transmit to 3rd Party - portal is separate from PACS, file sizes are
large, "reference" images might be sufficient, use CD rather than
on-line, DIRECT is too new to adopt, transmission begs the question of
to whom and recipients can't handle images

SRSoft
- Imaging - the DICOM images are in the PACS and the EHR does not have
them so don't specify a format - need to specify either a limited
number of systems or a standard for the link to where the images are
needs to be specified (this seems to contradict their request not to
specify a format) - Download and Transmit to 3rd Party - usual comment
that it is the PACS's responsibility and not the EHR's

American Academy of Ophthalmology
- View, Download and Transmit to 3rd Party - applauds the adoption of
DICOM but wonders how imaging equipment vendors work with the EHR and
ask is it OK to have a separate "image management system" (yes ! someone
who gets the idea that Certified EHR Technology is distinct from a
monolithic EHR system)

American Academy of Pediatrics - general comment "appropriate
and necessary standards and implementation specifications do not yet
exist to allow for the accessing of images and imaging results through
certified EHR technology" (wow, that's depressing)

JBS International - View, Download and Transmit to 3rd Party - concurs with the use of DICOM and "supports
that greater image sharing capabilities for patients will empower
individuals with and without a disability to have a greater role in
their own care coordination and reduce the amount of redundant and
duplicative imaging-oriented tests performed" - also comments on the
need for the download and transmission capabilities to be universally
accessible to support those with disabilities

Society for Participatory Medicine - Imaging - support streaming links "without
the delay related to use of DICOM file transfer and without the
requirement to install additional software beyond the standard web
browser itself" (presumably they are referring to a zero footprint
viewer) - also emphasize that patients should have same access as
providers (yeah, patient empowerment) - and in a second comment
that it should made made available to the patient at the same time as
soon as it is made available to the physicians - and in a third that four business days is "barely acceptable" and 48 hours would be preferable

Markle Foundation - general comment - "When
the VA enabled patients to download their information, the private
sector responded by demonstrating a wide range of applications that made
that information useful to patients (e.g., making it easier to know
when to take medications, storing medical images, and connecting with
peers who have similar health conditions)." (I guess by the way, that the ONC didn't conclude that if the VA can do it, private industry can)

Guthrie Health
- another Epic user but these guys actually made (some) of their own
comments - Imaging - results OK but NOT images - concerned about
bandwidth consumption in their rural setting and that "a single reader will not all allow viewing of all imaging formats" - View, Download and Transmit to 3rd Party - just quoted the standard Epic spiel

Bill Russell MD Health IT Consulting - Imaging - "immediate access to images from certified technology is of high value to [long-term post-acute-care]
LTPAC physicians ... addresses a weakness in diagnostics in the
setting, where studies are obtained portably, equipment and positioning
are suboptimal"

ACR
- Imaging - strongly supports - agrees with single sign on - encourages
interaction with radiology community and mentions WADO as an example of
something ONC should be familiar with (you mean to say perhaps they
weren't ?) - View, Download and Transmit to 3rd Party - silent on this,
sadly

New York Hospital Queens - Imaging - wanted clarification that this did not include photography or ECGs - states that "the technology has not matured yet to facilitate exchange [of images]"
- also says there are no standards for ECG exchange (yes there are, too
many of them) - mentions the need for a CCOW-like function for
synchronizing the patient and study and authenticating the user

CPSI
- Imaging - PACS and EHR are separate - link only - no single sign-on -
View, Download and Transmit to 3rd Party - images are in separate PACS -
norm is CDs with viewer - viewing not possible via portal - download
technically difficult - "identify the location of a study to be referred to another provider" (same language as EHR Association)

Kentucky Governor's Office of Electronic Health Information
- Imaging - clarify images versus results - images are big - is a link
sufficient or must EHR copy? - View, Download and Transmit to 3rd Party -
didn't address images specifically but did expect that transmission of
data to HIE through which patient should interact should suffice in lieu
of access through a portal

STI Computer Services
- Imaging - same language as EHR Association - no single sign-on -
View, Download and Transmit to 3rd Party - includes parts of same
language as EHR Association

Intermountain Healthcare - Imaging - does not support access to images through the EHR - "the
infrastructure to display images from all possible modalities, along
with all possible technology solutions within the ambulatory setting,
would require huge numbers of costly interfaces to integrate the images
into the EHR technology"- View, Download and Transmit to 3rd Party - "does not support unbounded expectations of downloading images that may contradict local or state policy"
(that's an interesting one; how could there be a local or state policy
that prevented patients from downloading their own images, which would
contravene the patient's access rights to their own record under the
HIPAA Privacy Rule ?)

GE Healthcare (both a covering letter, and the public comment form filled in) - Imaging - access via link not copy and no single sign-on (standard EHRA "beyond the control"
spiel) - View, Download and Transmit to 3rd Party - covering letter is
silent on this, but the comment form describes images as being in the
PACS not the EHR, how the provider may have a link but not the patient
portal, DICOM images need a specialized viewer and are too large, and
recommend against "the DICOMS [sic]" being a stage 2 criterion, industry standard is CDs with "pertinent" images, and "view technology does not allow such capabilities via a portal" - for download they say "getting
access to images in order to enable download will be a challenge ... we
suggest for Image Download that patient ability to identify the
location of a study to be referred to another provider as the
certification criterion" (standard EHRA language)

UNC Health Care - asks if the PACS have to be certified if it provides the image viewer launched from the certified EHR?

Missouri State Chiropractors Association - View, Download and Transmit to 3rd Party - requiring DICOM or even digital images is an "undue burden on the chiropractors and other smaller medical providers who do not have a digital system" - shouldn't have to scan in plain films

Greenway Medical Technologies
- Imaging - which "imaging tests" included ? - will patients link
through PACS with another login ? - what about security ? - single
sign-on is beyond the control of the EHR (standard EHR Association
language again) - View, Download and Transmit to 3rd Party - entire EHR
Association boilerplate

Texas Medical Association - Imaging - link from EHR to inpatient radiology systems is OK, but "for
ambulatory EHRs, image and report interfaces are not yet standardized
to where all radiology system vendors are using the same interface so
that physicians do not require a separate interface for each system" (this may be true for reports but I am surprised they think that is true for the images)

Patient Privacy Rights and a second copy
- Imaging - patients should be able to "receive" images - View,
Download and Transmit to 3rd Party - four days is far too long, should
be real time

ICSA Labs
- Imaging - need narrative as well as images so change "and/or" to
"and" - View, Download and Transmit to 3rd Party - [for any information]
transmission is too burdensome for provider, should place the
responsibility [for transmission] on the patient or other entity (I
guess they are trying to distinguish between downloading and
transmission)

Radiology Business Management Association - Imaging - agree - View, Download and Transmit to 3rd Party - 'EHRs
should be both "image enabled" to view images via such links and
capable of downloading and uploading images from portable media (e.g.,
CDs)'

Minnesota eHealth Initiative - Standards to Access Information - should include simple formats like JPEG or TIFF - "not practical for patients to have DICOM viewers in their iPads/laptop at home"
(not sure why they think TIFF images are so easily viewable) - View,
Download and Transmit to 3rd Party - real time is burdensome should be
"on request"

Philips Healthcare
- Imaging - discusses DICOM WADO at length and suggest establishing a
set of minimum security requirements then evaluating WADO versus many
current PACS "non-standards based approach" - also asks if EHR with link
to PACS need to be certified as bundle" or separately - View, Download
and Transmit to 3rd Party - silent (with respect to images)

First Insight Corporation
- Imaging - worried about dependency on "imaging vendors" - how does
CMS "enforce" this on imaging vendors (? required to be certified) and
how is security of imaging system handled

NextGen Healthcare
- Imaging - support link, opposed to storing images in EHR, opposed to
single sign on - View, Download and Transmit to 3rd Party - images are
on PACS, suggest HIE or continue to use CDs with viewer - images are big
and complex

Wisconsin Statewide Health Information Network - Imaging - "EHRs should support imaging functionality" and "support integration with an HIE for image query, retrieval, and viewing"-
View, Download and Transmit to 3rd Party - support, but recommend HIE
for the transmit portion (not an imaging-specific comment)

Quality Health Network
- Imaging - is a link OK ? - clarify if results or images - where will
these large files be stored ? - View, Download and Transmit to 3rd Party
- many concerns not specific to images but include suggestions to "just
start with results" and use an HIE community portal

Success EHS
- Imaging - express concern about the lack of specificity and standards
and means to comply with single sign-on - lead to high cost of
implementation and impact on other interfaces - View, Download and
Transmit to 3rd Party - object to "enormous" DICOM files and download is
not supported by their product

Athena Health - Imaging - "support the comments of the EHRA" - link and no immediate access (single sign-on) - View, Download and Transmit to 3rd Party - "support
the suggestion of EHRA to provide patients with the ability to identify
a study for transmission to a referring provider instead of requiring
functionality that provides patients with access to images for download"

New York State Department of Health - Imaging - agree - "Would
like to see the images imported directly and not have to be done
manually. Also important to be able to share this information with other
providers." - View, Download and Transmit to 3rd Party - agree, but who will pay for the expenses ?

T-System - Imaging - supports on the assumption that link not importation is OK - want "immediacy" clarified "so
as not to impose requirements on system technical performance, but to
require that systems enable access in a fashion that minimizes the
burden on the user" (? contradiction in terms ?) - View, Download and Transmit to 3rd Party - "generally agree" (no specific negative comment about images)

QuadraMed Corporation - Imaging - link and no single sign on (standars EHR Association text) - also suggest having image in two locations would "cloud the legal medical record ... if ... in any way modified ... during its incorporation into the EHR" (an interesting point, depending on what the recipient acts upon and the consequence of that action)

Office of Health Information Technology
- Imaging - agree, including without havibg to login to a separate
system - View, Download and Transmit to 3rd Party - agree with
requirement to download as DICOM - "this will promote
interoperability and exchange, reduce redundant and duplicative
imaging-oriented tests performed, and empower patients to take a greater
role in their own care coordination"

Kaiser Permanente - Imaging - "ONC’s
proposed certification criteria would require direct access to imaging
results ... but without requiring specific standards. We support a
flexible approach to standards at this point in time" (not sure what they mean by this; do they want standards or do they not ?) -"the
term “imaging”encompasses a wide array of data types; thus we recommend
limiting this requirement to radiologic images only for Stage 2, with
the corresponding certification testing to include only radiologic image
access" - View, Download and Transmit to 3rd Party - oppose entirely (not specific to images) "in
part because such capability would require a more sophisticated set of
tools and interfaces than what is enabled by the secure messaging
specifications for provider-to-provider exchange"

New Jersey Health Information Technology Extension Center - Imaging - "may
be challenging for the EHR vendor to be able to include the ability to
view images and/or narratives from the inpatient to outpatient setting
and more so bi-directionally" - View, Download and Transmit to 3rd Party - no comment

Healthwise - Imaging - "a copy of the image, e.g., advanced jpeg is satisfactory" (what is an "advanced" JPEG, one wonders?) - View, Download and Transmit to 3rd Party - no comments specific to images, but they did mention "should accommodate patient generated data to 'upload' into the EHR" (which would be interesting if one considered what that would mean for images)

Memorial Healthcare System
- Imaging - agree that DICOM is not necessary for this criterion -
View, Download and Transmit to 3rd Party - paraphrase standard EHRA
opposed language

American Hospital Association - Imaging - described results of survey (Fall 2011) that showed 66% of hospitals had "PACS for Imaging Results" but comment that "it is not clear, however, that these images are always available through the EHR" - "recommend
that ONC explicitly not require that the source of the image be
certified, as many images are created in many different modalities" - View, Download and Transmit to 3rd Party - "very
concerned about the practical implications of requiring the
distribution of diagnostic images in this way [DIRECT], as they are very
large and generally require use of specialized software to view.
Radiology reports may contain more useful information with much lower
technical requirements" - "Images are generally very large files,
and would require that the individual downloading or receiving the file
have specialized, expensive software to access the images. The effort
required to make the images available would be tremendous"

Sharp Healthcare
- Imaging - "and/or" question about images vs. narrative - and if it is
"and" images, just radiology, or also cardiology and pathology
(recommend only radiology) - also recommend "that the image required is clinical quality rather than diagnostic" (aargh ! I can already imagine the gnashing of neurosurgeons' teeth and the salivating of plaintiffs attorneys)

American Dental Association - Imaging - ADA has adopted DICOM for image exchange, and believes "that the use of the DICOM format is highly desirable", but agrees DICOM is not needed for the viewing objective

Partners Healthcare - Imaging - focus on report not images themselves - "in most cases, the text report is most meaningful to the ordering provider" - "many
studies that result in one or more images when the image itself is
intentionally never released to the ordering EP (barium swallow, cardiac
cath, interventional radiology, etc.)" (an interesting comment, but if it is part of the medical record, should it not be available ?) - "it is unreasonable to require image exchange ... [if] a link to an external system accessed through the EHR is acceptable ... it is impossible to require the EP to take responsibility for transmitting data that is not housed in his/her CEHRT"
(their use of impossible is hyperbole; anything is possible albeit
possibly technical challenging, e.g., to pass on a request to transfer)

Spectrum Health - Imaging -
narrative and decision support (appropriateness criteria) may be
sufficient to prevent overuse compared to images - clarify "and/or" -
clarify that link is sufficient and images don't have to 'reside" in EMR
- clarify limited to images read by a board-certified radiologist
[presumably they are trying to exclude in-office imaging by
non-radiologists like neurologists etc.] - View, Download and Transmit to 3rd Party - concerned that images may be burdensome because "it requires a single vendor for both imaging and EMR" and "Cerner and Epic for example do not have the top rated imaging software" - completely opposed to transmission (of anything) to a 3rd party

American College of Cardiology - Imaging - "standards for the transmission of 3-D echocardiography images ... lag behind" (fair comment, though the standard is there, just not the implementation by the vendors) - also concerned about adoption "image
viewing relies on the employment of a strict DICOM standard that does
not exist today ... physicians continue to receive studies on disk that
cannot be read by a PACS system, let alone an EHR" so recommend against core measure - but "the
imaging-related provisions ... of [the] standards, implementation
specifications and certification criteria do not go quite far enough ...
many vendors of cardiovascular imaging equipment claim that the format
of stored files is DICOM compliant; however, the reality is that this is
frequently not the case ... the ability to view a “DICOM compliant”
study created by one vendor with a second vendor’s DICOM viewer that is
not guaranteed ... this problem permeates the market ... ONC clearly
fails to appreciate this reality, at least not for cardiovascular images
... to execute successfully, the specific components of DICOM
compliance need to be specified ... ACC urges ONC to include this
requirement in the final rule." - they also say "require that the viewer application maintain theaspect ratio of the original image (i.e., square should remain square), rather than reflect theaspect ratio of the monitor" (wow, are there EHR viewers out there that are really that lame?)

Keith Boone (personal comments, not on behalf of GE) - "I
very much would like the opportunity to download my images, but not all
practices have the tools to manage patient images. This capability is
more common in specialty practices and hospitals that use imaging
frequently. I urge ONC to keep this capability, but to make it optional,
so that providers who use a lot of imaging can support it. I also
strongly support the use of the DICOM standard for images formats. While
patients may not readily have DICOM viewers, it is clear that they are
able to locate them on the web, and there are numerous freely available
viewers that can be found. Smart providers and vendors supporting the
View/Download/Transmit capabilities can readily make links to these
DICOM viewers available."

American College of Physicians - Imaging - "though
we support the use of DICOM for many purposes, we agree that the DICOM
standards should not be required for displaying images and their
associated narrative" - View, Download and Transmit to 3rd Party - "we
support the availability of DICOM capability but not to the exclusion
of simpler mechanisms for delivering images e.g. images as JPEGs, as
JPEGs or TIFFs within Word documents or PDFs, and the way they are often
delivered to doctors at present"

Healthcare Management Systems - Imaging - link to PACS only - in the future use HIEs - View, Download and Transmit to 3rd Party - "The
requirement to have images available for view, download and
transmission will be very difficult and may cause technical issues
resulting in poor performance and increased provider and patient
dissatisfaction with the EHR"

Future Health - Imaging - a DICOM image should not be required - "in review with the patient a jpeg ... is acceptable" (good point, but review with a patient is not the only EHR use case) - access should be restricted to those the EP ordered "rather than all images on record for the patient" (why???? doesn't the EP need all available information for decision making?) - how long must access be for (contrast with retention requirements), esp."immediate" access

Adventist Health System - Imaging - restrict to radiology - convert to JPEG due to large file sizes - View, Download and Transmit to 3rd Party - again, restrict to radiology and convert to JPEG due to large file sizes - "do not believe diagnostic quality is necessary for patient viewing"

HealthFusion - View, Download and Transmit to 3rd Party - DICOM images large and costly to duplicate - "point-to-point connectivity with multiple radiology centers places and unfair burden on EP" - suggest store in one place and exchange just the link to be the method to make both report and images available

Siemens Healthcare - Imaging - suggest access via pointers to PACS viewers only (not copy of images into EHR) - "reference pointers as metadata in APIs" - also suggest PACS viewer certification mechanism - View, Download and Transmit to 3rd Party - make modular criterion to allow base EHR to integrate with others -
clarify which 3rd parties (not friends and relatives) - SMTP (part of
DIRECT) is not suitable for transmitting images - suggest focus on "ability to view and download images by known, registered patients and their authorized, registered representatives" - suggest excluding images from EHR Technology and instead "including this as part of a supplemental certification ability for HIT that complement the EHRT" - until then use CD/DVD/USB per IHE PDI

Cerner -
Imaging - what does "and/or" mean - suggest images "and" narrative -
just radiology or also cardiology and pathology - suggest cardiology OK
but not pathology - suggest a "basic viewer" (panning, zooming,
scrolling a stack) is required not just static small images or embedded
images in reports - View, Download and Transmit to 3rd Party - should be consistent with Imaging rule - "do not believe diagnostic quality is necessary for patient viewing so do not suggest a standard for image viewing for patients
... original images may be provided to the patient portal or PHR with
diagnostic quality viewing enabled, but the diagnostic quality viewing
capability should not be required of the system supporting the patient
access for viewing" - DICOM format download of diagnostic quality
images should be required (e.g., to allow patient to burn their own CD) -
separate certification criteria if optional - DIRECT should not be used
due to large file sizes - JPEG capability should also be present for
transmit - clarify that data must be transmitted, not just link (static
links may go stale) - how long must remain accessible

Steindel, Steven - Imaging - "DICOM
is the standard used by the medical imaging community and is required
for diagnostic quality images ... DICOM embraces other common image
formats that are also medically useful such as JPEG but that is not
generally recognized ... criteria should be silent as to specific
standards but provide suggestions for common ones and perhaps a short
description of when use of that standard is appropriate" - View, Download and Transmit to 3rd Party - no image specific comments

And
that's it ... whew ... I don't envy the job ONC must have had sorting
through all these ... my interpretation will follow in a subsequent
post.

2 comments:

You now see and understand the massive effort that went into the authoring of these rules.

And you've only looked at ONE criterion. I understand that a handful of people worked 80 hour weeks all summer long in order to complete this work.

Add to this the research that is required to validate (or invalidate) the implications or suggestions that each and every commenter provides.

.. and then consider the necessary alignment with the policy goals of the administration, priorities of other Federal agencies - and (finally but most important) what's best for the patient - and you understand the complexity of all of what goes into the rule-making process.

Your concerns exist among the breadth of concerns that have been raised by many. You agree with some - and not others - and this is to be expected. It's the way that regulations are created. The final result wasn't what you wanted. But that doesn't mean that there is a conspiracy - or that one organization (as you blogged earlier in the week) has deeper influence than any other .. and if you think that Epic's redundant comments parroted by their many customers counted as anything more than one opinion - you underestimate the aptitude of our friends at ONC and CMS. They weren't born yesterday, ya know.

To say that ONC or CMS "wimped out" is - I would argue - a cowardly snipe from the sidelines that doesn't acknowledge the careful thought, hard work and serious deliberation that went into each and every decision.

There was no "wimping out" here.

As a primary are physician who cares deeply about patient engagement, transparency and patient access to data - my view is that ONC hit the nail right on the head on this criterion. It can and will evolve over time. As it should.